Study on Using Intensity Modulated Total Marrow Irradiation with Fludarabine/Busulfan for Transplant in High-Risk AML and Myelodysplastic Syndromes

Sponsor: University of Illinois at Chicago

Sponsor score: 0

ClinicalTrials ID:NCT03121014

This clinical trial is testing a new approach to prepare patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) for a stem cell transplant. The study combines a special type of radiation therapy with chemotherapy before the transplant.

Patient Parameters

Program Overview

This Phase II study is exploring whether adding intensity modulated total marrow irradiation (TMI) to the standard chemotherapy regimen of fludarabine and busulfan can better prepare patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) for an allogeneic stem cell transplant. The goal is to improve the effectiveness of the transplant by using this combination treatment.

Description

In this study, patients will receive a combination of treatments to prepare for a stem cell transplant. This includes:

  • Fludarabine, a chemotherapy drug, given through an IV for four days, starting five days before the transplant.
  • Busulfan, another chemotherapy drug, given through an IV for four days, starting five days before the transplant.
  • Thymoglobulin, an immune-suppressing drug, given through an IV for three days before the transplant, but only for patients receiving stem cells from unrelated or mismatched donors.
  • Intensity modulated total marrow irradiation (TMI), a type of radiation therapy, given for three days before the transplant.

On the day of the transplant, patients will receive the stem cells. To prevent complications like graft versus host disease (GVHD), patients will also receive medications such as tacrolimus and methotrexate. After the transplant, patients will be monitored regularly to assess their recovery and the success of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 65 years.
  • Diagnosed with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) that meet specific criteria, such as:
    • AML that has returned or not responded to treatment.
    • AML in first remission with poor-risk features.
    • MDS with poor-risk features or that has not responded to standard treatments.
  • Must have a suitable stem cell donor, either a sibling or an unrelated donor, who matches specific genetic criteria.

Exclusion Criteria

  • Significant health issues, such as:
    • Heart function below 50%.
    • Poor kidney function.
    • Liver problems, unless due to specific conditions.
    • Lung function below 50%.
    • Low overall health score.
    • Active viral infections like hepatitis or HIV.
    • Liver cirrhosis.
  • Pregnant individuals.
  • Inability to provide informed consent.
  • Previous radiation treatment to more than 20% of bone marrow areas.

Locations

FACILITYZIPCITYSTATE
University of Illinois at Chicago60612ChicagoIllinois

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